Our 26th Year of Publication
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Cover Story

Challenges and Opportunities For Medical Disposables & Implants Industry in India


Stakeholders need to take cognizance of the fact that it is not a desirable situation for a country with over a billion population to be 70 per cent import dependent on medical devices. Besides affordability of healthcare (which is currently 75 per cent out of pocket), the three pillars of medical technology remain safety, quality and efficacy of devices. At present, there is no nodal agency for assessing and evaluating technology in India.


The government should have a separate department under the Ministry of Health and Family Welfare (MoH&FW). The medical devices cater more to the healthcare than the pharmaceutical sector. Too many governing bodies with diverse requirements and standards, viz Department of Pharmaceuticals, Bio Technology, Telecommunications, Ministry of Environment and Forest, Ministry of Science and Technology, Ministry of Commerce, are hindrance to promotion of new technology. These affect ease of doing business as the decision making becomes slow. For the industry to grow and make it a hub, we need a nodal department which focusses on the segment.


Product performance reports are a globally accepted means of showing efficacy of medical technology, an aspect which has not found the same degree of importance in drafting policy and regulation. In other words, a onesize-fits-all approach may not work here and careful mapping of the medtech landscape is needed to identify the devices and equipment that are viable to making in India.


National Pharmaceutical Pricing Authority’s (NPPA) and Department of Pharmaceuticals are in discussion about categorization of medical devices into different segments for the purpose of fixing of trade margins. But the medical devices industry is continuing to be divided on the move of rationalization of trade margins. Rationalization of the price is necessary through an average pricing formula. The industry also suggests :


• Transparent and evidence based pricing and reimbursement policies should be promoted
• No arbitrary price control mechanisms should apply
• Recently Government broadened Medical Device definition to attract FDI. – delinked with D&C Act – (Same should apply for Rules & Regulations)


The industry welcomes CDSCO’s recent notification on waving off ADC/NOC condition of export consignments to all countries. This was a long standing demand of domestic manufacturers. This waiver of ADC/NOC will reduce the procedures for export clearance from the port where shipments were getting delayed for requirement of additional paper work. This is an important step taken by CDSCO to accelerate exports and reduce bottle necks for domestic manufacturers.


Also, the Ministry of Environment and Forest notified last month exclusion of Blood Bags from Bio Medical Waste Management Rules. The rules suggested phase out use of chlorinated plastic bags and gloves. The industry is concerned as there is no alternative to some of the chlorinated bags (Urine Bags, Drainage bags etc.).


The removal of existing barriers for growth & innovative initiatives from government will ultimately lead to increased investment in the Indian Medical Devices Industry by domestic and global players alike, whether in the form of local manufacturing, fostering Research & Development and Innovation, partnerships for skill development, among other things.


All stakeholders can work together today to contribute for the future vision of “Affordable and quality healthcare to all”.


Poly Medicure Ltd.

Poly Medicure Ltd is one of the leading medical devices manufacturer and exporter from India with dominant position in medical consumables market over 20 years with focus on innovation, safety and quality and have a vision of a world with highest quality of healthcare is made available to all. POLYMED have 5 manufacturing facilities in India (3 facilities in Faridabad and 1 each in Jaipur and Haridwar), 2 facilities overseas (One facility in China – wholly owned subsidiary and One joint venture in Egypt.)

Poly Medicure has spent Rs. 60 crore on the new green field project at IMT Faridabad, another 50-60 crore will be spent on the capacity expansion, automation and new products to be launched. Polymed produces over 100 different types of medical devices, the category ranges from Infusion Therapy, Central Venous Catheter, Blood Management System, Surgery and Wound Drainage, Anesthesia, Urology and Dialysis. With 98% percent of products of the renal care imported, the company will launch portable artificial kidney dialyser, which will help in continuous blood cleansing. A filter developed indigenous in India will help decrease the cost and more people will be able to afford it.



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